The present invention relates to novel compositions and their use. In particular, this invention relates to the use of 4,4xe2x80x2-methylenebis(tetrahydro-1,2,4-thiadiazine)-1,1,1xe2x80x2,1xe2x80x2,-tetraoxide, commonly known as taurolidine, as a neutralizing agent in the destruction of blood-borne pathogens during the blood collection and storage process. In solution, taurolidine is present in equilibrium with taurultam and methyloltaurultam.
More particularly, the present invention relates to a sterile blood collection system for transfusion which includes the addition of taurolidine to eliminate pathogens from the collected blood, especially pathogens associated with sexually transmitted diseases such as the AIDS virus, syphilis, gonorrhea, genital herpes simplex, and the like.
According to recent studies, it is estimated that between one and two million people are seropositive in the United States for HTLV-III virus and are most probably carriers that can transmit the virus. Because of the increased prevalence of the HTLV-III virus in the general population and its long incubation period of up to seven years. AIDS-related transfusions are likely to be implicated in more and more cases. The above mentioned studies reveal that current tests used to screen blood donors may reduce AIDS-related transfusions but are far from eliminating them.
Researchers at the Centers for Disease Control reported that xe2x80x9cThe epidemiologic pattern of transmission of AIDS is strikingly analogous to that of Hepatitis B, e.g. from person to person, through sexual contact and through exposure to blood and its productsxe2x80x9d (D. Peter Drotman, JAMA, Aug. 23-30, 1985-Vol 254, No. 8, Questions and Answers, page 1085). According to the Technical Manual of the American Association of Blood Banks, Ninth edition, 1985 page 349: xe2x80x9cTransfusion-associated Hepatitis B decreased since blood banks switched to predominately volunteer blood and adopted mandatory Hepatitis B surface antigen (HBsAg) screening of all donors. However, despite the most sensitive tests for HBsAg detection, occasional cases of Hepatitis B continue to occur after transfusion.xe2x80x9d Clearly, more effective techniques than screening tests are needed to avoid the spread of life-threatening pathogens such as HTLV-III through transfused blood.
According to current transfusion practice, blood is collected as whole blood containing all the blood components: Plasma, Packed Red Cells, Platelets, White Cells (Leukocytes) and coagulation factors. Using different centrifugation protocols, the whole blood can than be divided into its components.
Often, at least two blood components are transfused to different patients from a single blood unit. Whole blood contains in general 40% packed red cells and 60% plasma. Once the packed red cells are separated, the blood becomes very thick and is usually diluted before transfusion.
According to the Food and Drug Administration (FDA) regulations, once the whole blood unit is collected, it is considered a closed (sterile) system and can be stored for up to seven weeks depending on the anticoagulant and preservative used.
The whole blood can be manipulated within the different bags of the original unit but no additional bag can be added. Once an additional bag is connected or a sample taken from the main blood bag, the system is considered opened and the blood has to be transfused within 24 hours or be discarded.